Senior Medical Writer

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Oversee the planning and preparation of high-quality clinical regulatory documents.

• Create protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Manage document execution and project management tasks, including the creation, maintenance, and communication of timelines.

• Coordinate contributions from cross-functional client teams, stakeholders, and internal resources such as quality control and publishing.

• Ensure that document development adheres to client processes, templates, and instructional materials.

• Act as a specialist in client document management systems, tools, templates, and procedures.

• Lead the development of document messaging in collaboration with clients.

• Analyze data and generate shell documents to aid in authoring.

• Organize and facilitate kickoff meetings.

• Oversee the resolution of review feedback and lead comment resolution meetings.

• Follow up with team members to address any outstanding review feedback.

• Maintain consistency across client programs regarding messaging, formatting, and presentation.

• Conduct literature searches as necessary.

• Perform peer quality-control reviews as required.

• Contribute to operational initiatives in medical writing, such as the development of templates, style guides, and reference management.

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer within the CRO/biotech/pharmaceutical sector.

• A Bachelor’s degree or higher in a relevant discipline.

• Experience in oncology, infectious diseases, or vaccines is preferred.

• Proven experience in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents is desired.

• Flexibility to work across various therapeutic areas.

• Experience in producing documents in accordance with established processes and templates.

• Familiarity with lean authoring methods and structured content management.

• Knowledge of ICH and US regulatory requirements; familiarity with international regulatory requirements is a plus.

• Proficient in Microsoft Word and other Microsoft Office applications.

• Experience with document management systems, collaborative authoring tools, and review platforms.

• Ability to adapt to new technologies and tools.

• Capability to work both independently and collaboratively while managing competing priorities.

• A service-oriented and proactive mindset towards project management.

• Strong skills in conflict resolution and negotiation.

• Excellent written and verbal communication skills in English.

• Must reside in Brazil and be legally authorized to work there.

🏝️ Benefits

• Full-time, permanent employment opportunity.

• Equal employment opportunity regardless of protected characteristics.